Signet Therapeutics Announces FDA Fast Track Designation for SIGX1094, a First-in-Class AI- and Organoid-Discovered Targeted Therapy for Diffuse Gastric Cancer

Today, Signet Therapeutics (hereinafter referred to as "Signet") announced,First-in-class Drug Discovery Pipeline Project Completed in Collaboration with XtalPi SIGX1094 Granted Fast Track Designation by the U.S. Food and Drug Administration (FDA).As an FDA special accelerated review mechanism for new drugs targeting serious diseases or unmet clinical needs, this designation is expected to significantly shorten the approval timeline for SIGX1094, expedite its market entry, and bring a novel treatment option to patients worldwide. This marks a new qualification following the FDA Orphan Drug Designation (ODD) granted to SIGX1094 in November 2024.

SIGX1094 is the core product developed by Signet Therapeutics based on its innovative "Organoid+AI" drug discovery platform, primarily used for treating diffuse gastric cancer and other advanced solid tumors. This drug is based on a novel therapeutic target independently discovered by Signet Therapeutics.Combined with XtalPi's AI+ Robotic Drug Discovery Platform, not onlyThe world's first Class I innovative drug developed by integrating organoid and AI technologies, and also a breakthrough drug that is expected to fill the gap in targeted therapy for diffuse gastric cancer.Currently, SIGX1094 has completed the first dosing in a solid tumor patient at Peking University Cancer Hospital, with the Phase I clinical trial led by Professor Lin Shen, an authoritative expert in the field of gastrointestinal tumors.

After receiving the FDA Fast Track designation, SIGX1094 will have more opportunities to communicate with the FDA during the subsequent development and approval process, which will greatly accelerate its market entry. Drugs that receive this designation also have the opportunity to enjoyAccelerated approval, priority review status, and rolling review of New Drug Applications (NDA), etc.Preferential policies.In November 2024, SIGX1094 was granted FDA designation for gastric cancer.Orphan Drug Designation`, can enjoy FDA`Priority review and approval, exemption from NDA application fees for new drugs, and a seven-year market exclusivity period upon approval.Policy support, such as the FDA's Fast Track designation and Orphan Drug status, will further accelerate the market entry of SIGX1094, benefiting patients in urgent need of effective treatment as soon as possible.

In the drug discovery and design of SIGX1094, Signet Therapeutics and XtalPi have deeply cooperated to target the innovative targets selected by Signet Therapeutics.Designed a preclinical candidate compound (PCC) with a novel molecular scaffold and superior overall drug-like properties in just over 6 months.，Greatly improving the efficiency of R&D; in efficacy evaluation, SIGNET utilizes its established organoid platform based on patient genomic characteristics to better screen for molecules that closely reflect the true responses of patients, thereby significantly increasing the potential success rate of clinical trials. From the discovery of a new target to receiving IND approval, Signet Therapeutics took just over three years.At the same time, SIGNET and XtalPi have multiple innovative cancer-targeted drug research and development projects underway.

SIGNET Takes the Lead Globally in Utilizing an "Organoid + AI" Innovative Targeted Cancer Drug R&D Model. The company has a deep collaboration with XtalPi, using AI technology to rapidly screen candidate compound molecules and relying on SIGNET's unique organoid disease model platform for efficacy evaluation and testing. This innovative model not only significantly accelerates the speed of drug development and increases clinical success rates but also marks the entry of drug development into a new era of highly efficient integration of IT and BT.

● CloseSignet Therapeutics ● 

SIGNET is a pioneer in the global "organoid + AI" drug development model, recognized as a specialized and innovative enterprise in Shenzhen and certified as a National High-tech Enterprise. The company originated on the campus of Harvard University and officially established its presence in Shenzhen by the end of 2020, having since secured nearly 220 million yuan in financing and project funding. Currently, the company has four drug pipelines, with the first pipeline developing SIGX1094, the world’s first targeted drug for diffuse gastric cancer. It has obtained IND approval from both the U.S. FDA and China’s NMPA, and received Orphan Drug Designation and Fast Track Designation from the U.S. FDA. The drug has now entered Phase I clinical trials.

SIGNET is not only the phonetic translation of Signet but also adheres to the vision of "full of hope, studying things to gain knowledge." The company leverages the crucial role of organoid disease models that closely resemble patients' genomic characteristics in drug efficacy evaluation and new target discovery. Combined with AI-powered screening, synthesis, and optimization of small molecule compounds, SIGNET develops first-in-class innovative targeted drugs. The company has a 1200㎡ R&D facility and a 500㎡ experimental animal housing area. SIGNET's organoid platform not only serves its own drug pipeline but also actively empowers large pharmaceutical companies in new drug development. Collaborative partners include Shenzhen Second People’s Hospital, the University of Hong Kong, the Hong Kong University of Science and Technology, Shenzhen Borya Pharmaceuticals, and Genuine Biotech, contributing to the birth of more innovative drugs.